ASH 2025 | HMAs or chemotherapy with venetoclax and gilteritinib for FLT3-mutated AML

So, the abstract actually covers our single-center real-world experience using the two regimens. The first one is with the hypomethylating agents that will be azacitidine or decitabine in combination with venetoclax and gilteritinib or using a quadruplet regimen of low-dose cytarabine, actinomycin D, gilteritinib, and venetoclax, so the main difference is in the backbone, these are either hypomethylating agents or two chemotherapy drugs. So, we’ve used these two regimens for FLT3-free mutated acute myeloid leukemia here in Vilnius and Lithuania. And we have enrolled a total of 39 patients into the study, of whom 22 were female. The majority of patients were relapsed refractory, 77%. The remaining 23% were newly diagnosed patients. The median age of the group was 65 years old, and the median ECOG was one. FLT3-ITD mutations were more common in 70% of patients, whether the remaining 30% had FLT3-TKD, or a combination of both mutations. So newly diagnosed patients received azacitidine, venetoclax, and gilteritinib, or decitabine, venetoclax, and gilteritinib. As for the relapsed refractory patients, they were treated with the low-dose cytarabine, actinomycin D, venetoclax, and gilteritinib regimen. The overall response rates in both newly diagnosed and relapsed refractory patients was 95%. The cumulative complete remission and complete remission with incomplete platelet recovery rate, that will be CR plus CRp, was 82% for all patients. So the efficacy was high. We are seeing almost all patients responding, and the majority of those responses are either complete remissions or complete remissions with incomplete platelet recovery. Half of the evaluable patients, or 50% of evaluable patients for MRD had achieved MRD negativity either by flow or by PCR assays. All responses were achieved after one cycle of treatment. So what we do see that the venetoclax plus gilteritinib plus the backbone of either HMAs or chemotherapy are working really fast in achieving responses. Importantly, we didn’t see signs of prolonged myelosuppression and the median time for neutrophil and platelet recovery in responders was 25 and 23 days, respectively. There were a few cases of prolonged myelosuppression. However, all of those cases were in the relapsed refractory subgroup. Importantly, 41% of patients were bridged to an allogenic transplant and that is actually 80 percent when we take into account only allogenic-eligible patients at baseline, so there were 20 patients who were deemed to be eligible for a transplant and 16 of them could proceed to an allogenic transplant after achieving a response, so this is a good bridging. The median overall survival was 25 months and the median relapse-free survival was 8.2 months. Importantly, the early mortality was rather low. It was 3% at day 30 and 10% at day 60. And all of those cases were in the relapsed refractory subgroup as well.

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